ACTRIS – basic introduction

RBM tool Agile reporting in Clinical Trials ACTRIS

Lots of information is to be found on this and the next pages, about this new agile product, that I can offer, if you prefer so.

Using this, setting it up for you, comes as an extra to the regular services.

I am sure that a live demonstration / walk through can add even more and make it a true experience. Feel free to reach out and I gladly will accommodate this. e.smeets@sic-est.nl

Background

Over the past few years working primarily as a CRA and Project Manager, I have come to realize that some scenario’s and team interactions can be improved, so to make team work more efficient and enjoyable. The relatively new Risk Based Monitoring approach, the risk-adapted tips for project management as a whole, and the availability of new technologies have certainly added to this.

I have been part of many teams, each working following its own procedures. The substantial experiences gained, were used to create/build ACTRIS.

Apart from the current RBM approaches already in use by many – with many ‘remote’ activities – the future will consist of even more ‘Distributed Work’. This is an ideal territory/habitat for ACTRIS. How to keep all team members informed and involved in risk-based approaches leading to higher data quality, and better data integrity? How to keep on top of things?

SIC now can offer ACTRIS as Software-as-a-Service, as an annual subscription. A Service Level Agreement will be in place, taking into account a fit-for-purpose solution to my clients.

For further reading: see next page.

A stand-alone Presentation covering ACTRIS is available (an HTML file opens in a new tab in your browser, and in it you can open/close the topics of your interest).

If you’d rather see and hear me tell about ACTRIS, two YouTube items are available:

  • a brief (9 minutes) YouTube movie, Edgar presenting ACTRIS from a virtual booth at the MAGI conference, June 2020
  • a brief (8 minutes) YouTube movie, Edgar presenting a walk-through of ACTRIS

About S.I.C.

Smeets Independent Consultant - SIC, is the full name of my/Edgar's company, established in 2003. I am a sole trader, in the Netherlands known as 'ZZP'. The company is registered with the Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered. I partner with (bio)pharmaceutical companies, start-ups, Institutions, investigators, or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. I have a few SOPs in place myself to cover the topics 'Physical and Digital Security', and 'GDPR; Preventive and Corrective Measures', in my home office. You are kindly invited to explore this website, and please DO contact me with any questions.

Services offered

In general I offer a rather straightforward, efficient set of services when setting up your research project/trial, and represent my client when following through during the execution of the trial(s). I always keep a lean, business-like approach in mind.
The tasks performed by me could be one of the following, by itself or combined:
  • Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)
  • Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
  • Quality Assurance when setting up your research project, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)
  • Data Management activities / (extended) Central Monitoring
  • Employ ACTRIS (see elsewhere) to manage any issues / potential risks
  • Train or coach other CRAs/monitors working on the same trial
  • Oversee Safety Reporting, provide follow-up if needed
  • Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline
    • In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl
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